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Zacks News
Alnylam (ALNY) Files MAA to EMA for Rare Disease Drug Vutrisiran
by Zacks Equity Research
Alnylam (ALNY) submits a marketing authorization application to the EMA for vutrisiran to treat adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
BeiGene's (BGNE) BLA for Tislelizumab in ESCC Accepted by FDA
by Zacks Equity Research
The FDA accepts for review BeiGene's (BGNE) BLA for tislelizumab to treat patients with locally advanced/metastatic esophageal squamous cell carcinoma after prior systemic therapy.
Apellis (APLS) Down on Mixed Data From Studies on GA Candidate
by Zacks Equity Research
Apellis (APLS) posts mixed top-line data from the phase III DERBY and OAKS studies testing pegcetacoplan in adults with geographic atrophy secondary to age-related macular degeneration. Stock falls.
Global Blood's (GBT) NDA & sNDA for Oxbryta Get Priority Review
by Zacks Equity Research
The FDA grants priority review to Global Blood's (GBT) sNDA for Oxbryta to treat SCD in children aged four to 11 years, as well as to its NDA for a pediatric weight-based formulation of the drug.
Precision (DTIL) Inks Deal With Tiziana for Cancer Candidate
by Zacks Equity Research
Precision (DTIL) signs an exclusive license agreement with Tiziana to explore the latter's fully human anti-CD3 mAb, foralumab, for treating various cancer indications. Stock up.
BeiGene (BGNE) Gets FDA Nod for Brukinsa Label Expansion
by Zacks Equity Research
The FDA approves BeiGene's (BGNE) Brukinsa for the treatment of adult patients with Waldenstrom's macroglobulinemia. This marks the second approval for the drug in the United States.
Stealth (MITO) Files NDA for Ultra-Rare Disease Candidate
by Zacks Equity Research
Stealth BioTherapeutics (MITO) files a new drug application for elamipretide to the FDA for the treatment of Barth syndrome, an ultra-rare genetic condition.
Bristol Myers' (BMY) sBLA for Orencia Gets FDA Priority Review
by Zacks Equity Research
The FDA accepts Bristol Myers' (BMY) sBLA for Orencia under a priority review to prevent moderate to severe acute graft versus host disease. A verdict is pending on Dec 23, 2021.
Paratek's (PRTK) Nuzyra Gets FDA's Orphan Drug Tag for NTM
by Zacks Equity Research
The FDA bestows an Orphan Drug designation to Paratek's (PRTK) marketed drug Nuzyra for the treatment of infections caused by Nontuberculous Mycobacteria.
Kodiak Sciences (KOD) Q2 Earnings Lag, Eye Candidate in Focus
by Zacks Equity Research
Kodiak Sciences (KOD) reports wider-than-expected loss for the second quarter of 2021. Pipeline development remains in focus for the company.